Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

March 8, 2002

Last Updated Date

August 13, 2009

Start Date ^ICMJE

March 2002

Primary Completion Date

May 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of cytopemic response [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Frequency of cytopemic response

Change History

Complete list of historical versions of study NCT00031980 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer

Official Title ^ICMJE

Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia

Brief Summary

RATIONALE: Cyclosporine may improve low blood counts caused by hematologic cancer.

PURPOSE: Phase II trial to study the effectiveness of cyclosporine in treating patients who have low blood counts caused by hematologic cancer.

Detailed Description

OBJECTIVES:

Determine the frequency of cytopenic response in patients with T-cell large granular lymphocytic leukemia treated with cyclosporine.

OUTLINE: This is a multicenter study.

Patients receive oral cyclosporine every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 4 months for 1 year and then every 6 months for 9 years.

PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 3 years.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care

Condition ^ICMJE

Anemia
Leukemia
Neutropenia
Thrombocytopenia

Intervention ^ICMJE

Drug: cyclosporine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

May 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of T-cell large granular lymphocytic leukemia
- Increased numbers of large granular lymphocytes in peripheral blood smears
- CD3+CD8+CD57+ immunophenotype by flow cytometry AND
- CD3+CD57+ cell count at least 2,000/mm^3 OR
- CD3+CD57+ cell count at least 500/mm^3 with clonal T-cell receptor beta gene rearrangement
Patients must have at least 1 of the following:
- Severe neutropenia (absolute neutrophil count (ANC) less than 500/mm^3)
- Neutropenia (ANC less than 1,000/mm^3) and recurrent infections
- Anemia (hemoglobin less than 9 g/dL)
- Thrombocytopenia (platelet count less than 50,000/mm^3)

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

NCI CTC 0-3

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics

Hepatic:

Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

Creatinine no greater than 2 times ULN

Other:

Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No concurrent chemotherapy

Endocrine therapy:

No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)
No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

No prior cyclosporine therapy for this leukemia

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00031980

Responsible Party

Richard L. Schilsky, Cancer and Leukemia Group B

Study ID Numbers ^ICMJE

CDR0000069246, CALGB-10003

Study Sponsor ^ICMJE

Cancer and Leukemia Group B

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Maria R. Baer, MD

University of Maryland Greenebaum Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP